Risperidone Cinfamed 0.5 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

risperidone cinfamed 0.5 mg film-coated tablets

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What risperidone cinfamed is and what it is used for
What you need to know before taking risperidone cinfamed
How to take risperidone cinfamed
Possible adverse effects
How to store risperidone cinfamed
Contents of the pack and other information

1. What risperidone cinfamed is and what it is used for

Risperidone cinfamed belongs to a group of medicines called “antipsychotics”.

Risperidone is used to treat the following conditions:

Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
Mania, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in an illness called “bipolar disorder”.
Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who are at risk of harming themselves or others. Alternative non-pharmacological treatments should have been tried previously.
Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorders.

Risperidone can help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before starting to take risperidone cinfamed

Do not take risperidone cinfamed:

if you are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, consult your doctor or pharmacist before taking risperidone cinfamed.

Warnings and precautions

Consult your doctor or pharmacist before starting to take risperidone cinfamed if:

You have any heart problems. Examples include irregular heart rhythms, a tendency to low blood pressure, or if you are taking medications for blood pressure. Risperidone may lower blood pressure. You may require a dose adjustment.
You have any risk factors that may predispose you to stroke, such as high blood pressure, cardiovascular disease, or cerebrovascular problems.
You have ever experienced involuntary movements of the tongue, mouth, or face.
You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
You have Parkinson’s disease or dementia.
You are diabetic.
You have epilepsy.
You are male and have ever experienced prolonged or painful erections. If this occurs while taking risperidone, contact your doctor immediately.
You have difficulty regulating your body temperature or feel excessive heat.
You have kidney problems.
You have liver problems.
You have abnormally high levels of the hormone prolactin in your blood or if you have a tumor that may be prolactin-dependent.
You or a family member has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Very rarely, patients treated with risperidone have developed a dangerously low count of a type of white blood cells essential for fighting infections. Your doctor may monitor your white blood cell count.

risperidone cinfamed may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking risperidone, your doctor should check for signs of elevated blood sugar levels. In patients with pre-existing diabetes mellitus, blood sugar levels should be monitored regularly.

Risperidone frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, evaluation of blood prolactin levels is recommended.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may fail to dilate as needed. Additionally, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You must not take risperidone if your dementia is caused by stroke.

During treatment with risperidone, you should see your doctor regularly.

If you or your caregiver notice a sudden change in your mental state or sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or if you experience confusion or slurred speech, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for behavioral disorders.

If you experience fatigue during treatment with risperidone, changing the time of administration may improve difficulties with attention.

Before starting treatment, your weight or your child’s weight may be measured and should be monitored regularly during treatment.

A small, inconclusive study has reported increased height in children taking risperidone, but it is unknown whether this is a drug effect or due to other reasons.

Other medicines and risperidone cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important to talk to your doctor or pharmacist if you are taking any of the following:

Medicines that act on the brain, such as those used to calm you down (benzodiazepines), or certain pain medications (opioids), or allergy medications (some antihistamines), as risperidone may increase their sedative effect.
Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders (e.g., quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
Medicines that cause a slow heart rate.
Medicines that cause low potassium levels in the blood (such as certain diuretics).
Medicines for high blood pressure. Risperidone may lower blood pressure.
Medicines for Parkinson’s disease (e.g., levodopa).
Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (e.g., furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

Rifampicin (a medicine used to treat certain infections).
Carbamazepine, phenytoin (medicines for epilepsy).
Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone:

Quinidine (used for certain heart conditions).
Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
Medicines known as beta-blockers (used to treat high blood pressure).
Phenothiazines (such as medicines used to treat psychosis or as sedatives).
Cimetidine, ranitidine (stomach acid blockers).
Itraconazole and ketoconazole (medicines used to treat fungal infections).
Some medicines used to treat HIV/AIDS, such as ritonavir.
Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone cinfamed.

Use of risperidone cinfamed with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid alcohol while taking risperidone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.
The following symptoms may occur in newborn babies whose mothers were treated with risperidone during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
risperidone cinfamed may increase levels of a hormone called “prolactin” which may affect fertility (see Possible side effects).

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

risperidone cinfamed contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

risperidone cinfamed contains the azo dye cochineal red A (Ponceau 4R) (E-124)

This medicine may cause allergic reactions as it contains cochineal red A (Ponceau 4R) (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

risperidone cinfamed contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take risperidone cinfamed

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dosage:

For the treatment of schizophrenia

Adults

The usual initial dose is 2 milligrams once daily. This may be increased to 4 milligrams once daily on the second day.
Your doctor may adjust your dose depending on your response to treatment.
Most people improve with daily doses of 4 to 6 milligrams.
This total daily dose may be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

The initial dose is usually 0.5 milligrams twice daily.
Your doctor may gradually increase your dose later to 1 to 2 milligrams twice daily.
Your doctor will tell you what is best for you.

For the treatment of mania

Adults

The initial dose is usually 2 milligrams once daily.
Your doctor may gradually adjust your dose depending on your response to treatment.
Most people improve with daily doses of 1 to 6 milligrams once daily.

Elderly patients

The initial dose is usually 0.5 milligrams twice daily.
Your doctor may gradually adjust your dose later to 1 to 2 milligrams twice daily, depending on your response to treatment.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

The initial dose is usually 0.25 milligrams twice daily.
Your doctor may gradually adjust your dose depending on your response to treatment.
Most people improve with a dose of 0.5 milligrams twice daily. Some patients may require 1 milligram twice daily.
The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

Use in children and adolescents

Children and adolescents under 18 years of age should not be treated with risperidone for schizophrenia or mania.

For the treatment of conduct disorders

The dose depends on your child's weight:

If your child weighs less than 50 kilograms:

The initial dose is usually 0.25 milligrams once daily.
The dose may be increased every other day in increments of 0.25 milligrams per day.
The usual maintenance dose is 0.25 to 0.75 milligrams once daily.

If your child weighs 50 kilograms or more:

The initial dose is usually 0.5 milligrams once daily.
The dose may be increased every other day in increments of 0.5 milligrams per day.
The usual maintenance dose is 0.5 to 1.5 milligrams once daily.

The duration of treatment in patients with conduct disorders should not exceed 6 weeks.

Children under 5 years of age should not be treated with risperidone for conduct disorders.

Patients with kidney or liver problems

Regardless of the condition being treated, all initial and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this group of patients.

Instructions for use

For oral use.

Swallow the medicine with a glass of water.

The score line is intended only for breaking the tablet if you have difficulty swallowing it whole.

Because the tablets do not divide into equal doses, other commercial presentations may be more suitable for some of the dosages described (e.g., 0.25 mg doses).

If you take more risperidone cinfamed than you should

In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or have abnormal heartbeats or seizures.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take risperidone cinfamed

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose and continue your regular schedule. If you miss two or more doses, contact your doctor.

Do not take a double dose to make up for missed doses.

If you stop taking risperidone cinfamed

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop treatment, your dose may be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Immediately inform your doctor if you experience any of the following uncommon adverse effects (may affect up to 1 in 100 patients):

You have dementia and experience a sudden change in your mental state, or sudden weakness or numbness of the face, arms, or legs—especially on one side—or difficulty speaking, even for a short period of time. These may be signs of a stroke.
You develop tardive dyskinesia (involuntary spasms or spasmodic movements of the face, tongue, or other parts of the body). Immediately inform your doctor if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone cinfamed may be necessary.

Immediately inform your doctor if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 patients):

You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required.
You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be required.
You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

Other side effects may also occur:

Very common adverse effects (may affect more than 1 in 10 people)

Difficulty falling or staying asleep.
Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of “freezing” of movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness.
Feeling drowsy or less alert.
Headache.

Common adverse effects (may affect up to 1 in 10 people)

Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.
Increased levels of a hormone called “prolactin” detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin occur rarely and may include, in men, breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, symptoms may include breast discomfort, milk secretion from the breasts, absence of menstrual periods, or other cycle problems or fertility issues.
Weight gain, increased appetite, decreased appetite.
Sleep disturbances, irritability, depression, anxiety, restlessness.
Dystonia: A condition involving involuntary, slow, or continuous muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
Dizziness.
Dyskinesia: A condition involving involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
Tremor (shakiness).
Blurred vision, eye infection, or “red eye.”
Rapid heartbeat, increased blood pressure, shortness of breath.
Sore throat, cough, nosebleeds, nasal congestion.
Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
Rash, skin redness.
Muscle spasms, bone or muscle pain, back pain, joint pain.
Urinary incontinence (loss of bladder control).
Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
Falls.

Uncommon adverse effects (may affect up to 1 in 100 people)

Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or body part, viral infection, skin inflammation caused by mites.
Decrease in a type of white blood cell that helps fight infections, decrease in white blood cell count, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in the blood.
Allergic reaction.
Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake.
Weight loss, loss of appetite leading to malnutrition and decreased body weight.
Increased cholesterol in blood.
Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
Seizures (epileptic fits), fainting.
Restlessness causing movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin.
Light sensitivity of the eyes, dry eyes, increased tearing, eye redness.
Sensation of spinning (vertigo), ringing in the ears, ear pain.
Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation on the electrocardiogram (ECG), slow heartbeat, abnormal electrical conduction of the heart (ECG), sensation of fluttering or pounding in the chest (palpitations).
Decreased blood pressure, decreased blood pressure upon standing—consequently, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting up suddenly, flushing.
Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, wheezing, voice disorder, difficulty breathing.
Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excess gas or flatulence.
Hives (or “urticaria”), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorder, skin lesion.
Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown.
Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
Frequent urination, inability to urinate, pain when urinating.
Erectile dysfunction, ejaculation disorder.
Loss of menstruation, absence of menstrual periods, or other cycle problems (in women).
Breast development in men, milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
Swelling of the face, mouth, eyes, or lips.
Chills, increased body temperature.
Change in walking pattern.
Thirst sensation, feeling unwell, chest discomfort, feeling “under the weather,” malaise.
Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.
Pain due to the procedure.

Rare adverse effects (may affect up to 1 in 1,000 people)

Infection.
Inappropriate secretion of a hormone that controls urine volume.
Sleepwalking.
Sleep-related eating disorder.
Sugar in urine, low blood sugar, increased blood triglycerides (a type of fat).
Absence of emotions, inability to achieve orgasm.
Lack of movement or response while awake (catatonia).
Problems in the blood vessels of the brain.
Coma due to uncontrolled diabetes.
Head agitation.
Glaucoma (increased pressure in the eyeball), eye movement problems, eye rolling, crusts at the edge of the eyelid.
Eye problems during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.
Dangerously low number of a type of white blood cell needed to fight infections in the blood.
Dangerously excessive water intake.
Irregular heartbeat.
Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
Inflammation of the pancreas, intestinal obstruction.
Swelling of the tongue, cracked lips, drug-related skin rash.
Dandruff.
Rupture of muscle fibers and muscle pain (rhabdomyolysis).
Delayed menstrual periods, increased mammary glands, breast enlargement, milk secretion from the breasts.
Increased insulin (a hormone that controls blood sugar levels) in blood.
Skin hardening.
Decreased body temperature, coldness in arms and legs.
Drug withdrawal syndrome.
Yellowing of the skin and eyes (jaundice).

Very rare adverse effects (may affect up to 1 in 10,000 people)

Life-threatening complications of uncontrolled diabetes.
Severe allergic reaction with swelling, which may affect the throat and cause breathing difficulties.
Lack of movement in the intestinal muscles causing obstruction.

Frequency not known: cannot be estimated from available data

Severe or life-threatening blistering and peeling skin rash that may start around the mouth, nose, eyes, genitals, and spread to other parts of the body (Stevens-Johnson Syndrome or toxic epidermal necrolysis).

The following adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with risperidone cinfamed: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those observed in adults. The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of risperidone cinfamed

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of risperidone cinfamed

The active substance is risperidone. Each risperidone cinfamed film-coated tablet contains 0.5 mg of risperidone.
The other components are:

Tablet core:

Pregelatinized maize starch, lactose, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate and magnesium stearate.

Coating:

Partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171), talc, iron oxide red (E-172), iron oxide yellow (E-172) and cochineal red A (Ponceau 4R) (E-124).

Appearance of the product and contents of the container

The 0.5 mg risperidone cinfamed film-coated tablets are oblong, biconvex, scored and brownish in colour.

They are marketed in packs containing 28 or 56 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid) - Spain

Farmalider S.A

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Generis Farmacêutica S.A.

Rua de João de Deus, nº 19

Venda- Nova. Amadora 2700-487 -Portugal

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of latest revision of this package leaflet: September 2022

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66804/P_66804.html

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